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Strategic Initiative on Cancer Vaccines

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1. About the Program

Following completion of Phase I of the D2R program, the advisory and governing bodies of D2R have recommended that an increased translational focus be given to Phase II of the initiative. This focus on translational outcomes for specific patient populations is to be achieved within the last four years of the program. Hence, the D2R program aims to implement a series of strategic initiatives with a strong clinical and translational focus that will improve patient outcomes for prioritized disease areas.

    1. About the Program (continued) 

    Messenger RNA-based vaccines targeting tumour-associated neoantigens, either cancer-type-specific “public” neoantigens or patient-specific “personalized” neoantigens, are emerging as promising therapeutic options for many difficult-to-treat solid tumors. Advances in the capacity to (a) characterize the genome and transcriptome of a tumor, (b) identify possible neoantigens, (c) rapidly derive mRNA-based and lipid nanoparticles (LNP)-delivered vaccine candidates, and (d) monitor the host-specific immune response to such vaccines, together position cancer vaccines as exciting prophylactic/therapeutic options for many types of cancer. The DNA to RNA (D2R) Strategic Initiative on Cancer Vaccines aims to support a small number of multidisciplinary translational projects to accelerate the development and clinical implementation of neoantigen-based cancer vaccines in prioritized patient populations.

    The D2R Strategic Initiative on Cancer Vaccines seeks to support translational projects that are sufficiently advanced and ready for clinical implementation, and that include first-in-human studies within the funding period. Projects should demonstrate a clear clinical and regulatory path for integrating cancer vaccines into cancer care, including improvement of patient outcomes for a specific cancer type(s). Funding from this program will support multidisciplinary teams that are uniquely positioned to integrate expertise and capabilities for successful clinical translation of a cancer vaccine program, including but not limited to:

    1. Access to appropriate patient populations that stand to most benefit from a novel, vaccine-based therapeutic approach (unmet clinical need, poor outcome), and where vaccine response and possible clinical benefit could be monitored over the funding period;
    2. Strong knowledge base and expertise in the cancer type being targeted, from molecular biology of the tumor type to surrogate markers of progression and/or recurrence in vivo;
    3. Clinical expertise in treatment of such cancers by standard-of-care and/or previous experience with clinical trials in that indication;
    4. Immunological expertise to monitor patient response to immunization in real time, including cellular and humoral parameters of protective immunity;
    5. Genomic medicine and RNA therapies;
    6. Clinical research and implementation of novel modalities including experience in regulatory affairs.

    Project teams are expected to include relevant stakeholders and establish the partnerships needed to support successful clinical translation and implementation. Working collaboratively, the D2R team will support the development of relevant industry partnerships and facilitate access to manufacturing expertise and other strategic resources for the production of GMP-grade reagents, such as RNA cargo, LNPs, and formulated products for clinical studies in humans.

    The program consists of a two-stage application process involving first a Letter of Intent (LOI), followed by an invited Full Application. A very limited number of projects will be funded. Successful projects will be expected to follow a milestone-driven development plan with clearly defined translational, clinical, regulatory, and implementation objectives. Funding will be provided in consecutive phases, with continuation contingent upon the successful achievement of pre-defined and pre-approved milestones.

    To support the strategic and translational objectives of this initiative, D2R will work collaboratively with invited and funded teams, as appropriate, throughout project development and execution. This may include facilitating access to relevant expertise, partnerships, manufacturing and regulatory resources, technology platforms, and other strategic resources to advance project objectives. This support will be provided by the leadership of the D2R Oncology Working Group.

    D2R is committed to advancing inclusive and impactful genomic medicine and RNA therapeutics. Applicants are expected to integrate Equity, Diversity and Inclusion (EDI) considerations into both research design and research practices. In addition, applicants are encouraged to consider strategies that support translation into practice and, where appropriate, commercialization of their innovations, including industry partnerships, intellectual property protection, and regulatory pathways. Projects generating substantial datasets are encouraged to leverage appropriate data science approaches and best practices for data management and analysis.

    2. Objectives

    Projects supported through the Strategic Initiative on Cancer Vaccines are expected to demonstrate:

    • Alignment with the Funding Opportunity: Projects must strictly focus on the development and clinical translation of innovative cancer vaccine approaches that address important unmet clinical needs. Projects must focus on a clearly defined therapeutic indication and justify its selection based on unmet clinical need, anticipated patient benefit, and the availability of an appropriate patient population to support the proposed translational objectives and measurable outcomes.
    • Clinical Translation and Implementation Readiness: Projects should be sufficiently advanced and ready for clinical translation and implementation within the funding period. Although the program may support lab-based studies required for advancement of the clinical program, projects with a strong focus on basic biochemical, molecular, or disease-focused preclinical studies for target discovery, target validation, surrogate markers of target engagement, or similar activities, will not be supported under this program.
    • Multidisciplinary Team and Clinical Expertise: Projects must bring together all the expertise and experience required to support clinical translation, including a strong nucleus of clinician-scientists with experience in clinical research and direct expertise in the targeted disease indication.
    • Technology Platforms and Infrastructure: Projects should demonstrate access to unique platforms required to conduct the research program, including but not limited to existing D2R funded platforms or equivalent resources for clinical-grade sequencing, data science (neoantigen mapping), immunophenotyping for humoral and cellular immunity, and any hospital- and lab-based infrastructure required for clinical studies. Selected teams will be expected to work with the D2R team to create partnerships with relevant local industry, to support successful first-in-human studies, including GMP manufacturing and timely delivery of mRNA, lipids and LNP formulations.
    • Partnerships and Institutional Commitment: Projects should demonstrate meaningful partnerships, including leveraged support, industry engagement (where appropriate), institutional commitment, and financial and/or in-kind contributions from partner organizations, philanthropy, and other financial sources that will be leveraged by the D2R funding, thereby maximizing the impact of the D2R investment for successful clinical implementation of the vaccine program.
    • Regulatory and Translational Pathway: Projects must include a clear translational development strategy addressing regulatory, manufacturing, and implementation considerations, supported by regulatory expertise and a defined pathway toward regulatory approval, where applicable.
    • Milestones, Deliverables and Feasibility: Projects should present a realistic plan with clearly defined milestones, deliverables, timelines, and budgets that support successful execution and evaluation of progress. Milestones should focus on achieving meaningful translational, regulatory, manufacturing, clinical, and implementation objectives rather than solely scientific advancement. D2R funding will be staged and strictly dependent on achieving a set of pre-approved research, clinical, and regulatory milestones.
    • Patient Impact and Health-System Integration: Projects should demonstrate a credible path to improving patient health, quality of life, or disease outcomes and show how the proposed approach could ultimately be integrated into the health-care system for sustainability.

    3. Funding and Duration

    • Award Value: Given the broad scope and requirements of projects eligible under this program, no pre-determined funding amount has been established. Applicants are expected to request a realistic and well-justified budget that aligns with and supports conducting the proposed activities at a competitive pace, including meeting project objectives, and clinical and regulatory milestones to be reached within the duration of the project period.
    • Duration: Individual projects will be funded for a maximum period of three years, with the possibility of an extension to a fourth year, subject to program requirements and available funding. The funding will be staged with a two-year mid-term review. Funding for the second tranche of the project will be based on achieving pre-determined milestones and deliverables, as reviewed by D2R staff and leadership and the Chair of the Oncology Working Group.
    • Leveraged Support: Although not compulsory, it is expected that D2R funds will be used to leverage additional significant resources to broaden the scope and breadth of the research program. Applicants should describe existing and/or anticipated financial and in-kind contributions from partner organizations and other funding sources that support the proposed project. The nature and extent of leveraged support should be appropriate to the scope, translational stage, and objectives of the proposed work.
    • Governance, Mentoring and Support: It is expected that all project leads will meet with the D2R Oncology Working Group approximately every six months to review progress, discuss challenges and opportunities, and identify ways to help advance project objectives.

    4. Key Dates

    • Program Announcement: August 3, 2026
    • Letter of Intent (LOI) Deadline: September 1, 2026, at 9 a.m. (Eastern Time). Late or incomplete LOIs will not be reviewed.
    • Notice of LOI Decision: October 1, 2026
    • Full Application Deadline: November 15, 2026
    • Anticipated Award Announcement: January 2027

    5. Eligible Expenses

    • Compensation: salaries, stipends, and benefits for highly qualified personnel, including graduate students, postdoctoral fellows, clinical research fellows, research assistants, technicians, project managers, and other personnel directly involved in the project; technical services, consulting fees, and honoraria
    • Supplies, User Fees & Consumables
    • Equipment, up to a combined maximum of $50,000 for small equipment.
    • Computers & Electronic Communications: hardware and software
    • Travel & Subsistence: accommodations and reasonable out-of-pocket expenses for meetings, conferences, collaboration activities, regulatory interactions, and partnership development
    • Dissemination & Networking: event hosting costs, publishing fees, and translation costs
    • Services and other expenses: expenses directly related to achieving the objectives of the project.
    • Training support should primarily be allocated to graduate students, postdoctoral fellows, clinical fellows, and other highly qualified personnel (HQP) who are already identified or realistically recruitable within the first year of the project. If funds are requested for future recruitment, applicants should provide a brief justification and anticipated recruitment timeline. To promote high-quality training and mentoring, applicants are encouraged to provide comprehensive support for trainees rather than partial support for multiple individuals

    All expenditures must comply with the .

    For any questions about eligible expenses, please contact the D2R office: D2R.Funding [at] mcgill.ca (subject: Centre%20and%20Institute%20Support%20Program)

    6. Project Team

    Given the translational nature of this program, successful teams are expected to bring together the expertise, infrastructure, partnerships, and clinical leadership necessary to support the development, regulatory advancement, and implementation of cancer vaccine approaches. Teams should demonstrate access to, or a realistic plan to secure, the resources required to achieve the proposed objectives.

    Principal Investigator (PI)

    • The Principal Investigator must be an eligible Թ faculty member.
    • The PI is responsible for leading the development, coordination, and execution of the project.
    • The PI is expected to be a clinician-scientist and lead a multidisciplinary team with strong expertise and experience in treatment of the targeted indication.
    • The PI, and co-PIs responsibilities in the execution of the project must be clearly defined.

    Co-Investigator(s) may include:

    • Eligible Թ faculty members
    • Faculty from D2R partner institutions —University of British Columbia, University of Ottawa, Université de Sherbrooke, and Institut de recherches cliniques de Montréal (IRCM) — who appear on the approved list of D2R-affiliated researchers submitted by each partner institution
    • Co-Investigators are expected to play active roles in project design, implementation, project governance, and execution as appropriate.

    Collaborators and Partners

    • Collaborators and partners may include individuals or organizations from academia, industry, government, health-care institutions, patient organizations, non-profit organizations, or community organizations.
    • Collaborators and partners may contribute expertise, infrastructure, technology platforms, patient access, manufacturing capabilities, regulatory expertise, implementation support, financial contributions, and/or other resources relevant to the project.
    • Applicants should describe the anticipated role and contributions of key collaborators and partners and how they will support the project's translational and implementation objectives.
    • Collaborators and partners are not eligible to receive D2R funds directly.

    7. Letter of Intent

    The LOI consists of an Online Form and specific documents to upload. Use the templates provided.

    7.1 Documents to Upload

    1. Letter of Intent (Template Link)
    2. Biosketches (Template Link) or Tri-Agency Narrative CV, for the PI and any Co-Is, combined into one PDF

    7.2 LOI Instructions

    Use the template provided. Maximum of 3 pages (English), or 4 pages (French). Address the following:

    A. Scientific Abstract

    • Provide an overview of the proposed project, including its objectives, cancer vaccine strategy, targeted indication(s), and expected outcomes.

    B. Clinical Need, Development Strategy and Innovation

    • Describe the unmet clinical need being addressed and explain how the project aligns with the objectives of this funding opportunity and D2R's mission in oncology.
    • Explain the rationale for selecting the proposed indication, including anticipated patient benefit, the availability of a suitable patient population, and its suitability for clinical translation and implementation within the funding period.
    • Provide an overview of the proposed development plan, including key activities, innovation, anticipated challenges, and major translational, clinical, and regulatory milestones.
    • Describe the anticipated impact on patients and clinical practice, including plans for engagement with patients, patient organizations, and/or other relevant stakeholders.

    C. Team and Feasibility

    • Describe the multidisciplinary team, key expertise, and the contribution of each investigator.
    • Summarize the technology platforms, infrastructure, manufacturing capabilities, regulatory expertise, and other resources required to support clinical translation. Describe existing access to these resources and explain how the team will address critical gaps necessary for successful project implementation.
    • Explain the feasibility of achieving the proposed objectives within the anticipated timeline and budget.

    D. Partnerships, Leveraging and Institutional Support

    • Describe existing and/or anticipated partnerships, including the nature of any financial or in-kind support, institutional commitments, and other resources that will contribute to the proposed project. Where available, briefly indicate the status of these commitments (e.g., confirmed or under discussion). Explain how D2R funding would contribute to the successful execution of the proposed project.

    Letters of support are not required at the LOI stage. However, applicants should identify key partnerships and anticipated financial or in-kind contributions. Invited applicants will be required to provide letters of support at the Full Application stage.

    E. Summary of Budget Request

    • Provide a high-level summary of the anticipated budget request, including the overall D2R funding requested, the major categories of expenditure, and any anticipated leveraged financial and/or in-kind support, where applicable.

    Appendices are not permitted. Additional pages will be removed prior to review.

    8. Letter of Intent Criteria & Evaluation Process

    8.1 Administrative Review

    Each submission will be reviewed for applicant eligibility and completeness of the LOI requirements.

    8.2 LOI Evaluation

    The LOI review will focus primarily on the strategic fit, translational readiness, feasibility, and overall competitiveness of the proposed project. Eligible LOIs will be evaluated through a multidisciplinary review process established by D2R using the following criteria:

    1. Clinical Need, Therapeutic Indication and Strategic Alignment
      • Significance of the unmet clinical need.
      • Appropriateness of the selected therapeutic indication, including anticipated patient benefit and availability of a suitable patient population.
      • Alignment with the objectives of the D2R Strategic Initiative on Cancer Vaccines
    2. Clinical Translation and Implementation Readiness
      • Readiness of the proposed project for clinical translation and implementation within the funding period.
      • Appropriateness of the proposed development strategy, including major translational, clinical, and regulatory milestones.
      • Suitability of the project for a milestone-driven strategic initiative, including the achievement of meaningful translational, regulatory, manufacturing, clinical, and implementation milestones.
    3. Team Expertise, Technology Platforms and Feasibility
      • Strength and complementarity of the multidisciplinary team.
      • Presence of clinician-scientist leadership and relevant expertise in clinical research and the targeted disease indication.
      • Availability of, or realistic plans to access, the technology platforms, infrastructure, manufacturing capabilities, regulatory expertise, and other resources required to support clinical translation.
      • Feasibility of achieving the proposed objectives within the anticipated timeline and budget.
    4. Partnerships, Institutional Support and Leveraging Opportunities
      • Appropriateness of existing and/or anticipated partnerships, institutional commitments, and other resources required to support the proposed translational and implementation objectives.
    5. Translational and Patient Impact
      • Potential to improve patient outcomes and clinical practice.
      • Plans for engagement with patient partners, patient organizations, and/or other relevant stakeholders, where appropriate.
      • Potential for integration of the proposed approach into the Canadian health-care system.

    9. LOI Notification

    Applicants will be informed of the outcome of their LOI application and will receive reviewer feedback by email.

    Applicants selected to proceed will receive information regarding the next stage of the application process. Invited teams will work collaboratively with D2R, the Oncology Working Group, and relevant subject-matter experts to further refine and develop their proposed projects prior to submission of the next-stage application. This may include partnership development, manufacturing and regulatory strategies, refinement of project scope, milestones, budget, and other elements required to strengthen the proposed project.

    Where appropriate, invited applicants may be asked to participate in discussions, workshops, or presentations to support project development and/or as part of the next stage of the application and review process.

    Additional instructions, templates, timelines, and evaluation criteria for the next stage will be provided to invited applicants.

    10. Contact Information

    For questions about the program and application process, contact: D2R [at] mcgill.ca

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